Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy

Carotid Artery Stenosis Clinical Trial

— SERIC-CASCEA  

Official title:

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy: A Pilot, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033963
• Other study ID #: SERIC-CASCEA
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 0086-13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

Description:

In this study, 100 patients with carotid artery stenosis receiving carotid endarterectomy are included in our center in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis receiving carotid endarterectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age=18 years, <80 years, regardless of sex;

2. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 50% (Based on North American Symptomatic Carotid Endarterectomy Trial Collaborators (NASCET) Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);

3. Baseline mRS 0-2;

4. Can cooperate with and complete brain magnetic resonance imaging (MRI) examination;

5. Signed and dated informed consent is obtained;

Exclusion Criteria:

1. Evolving stroke;

2. Chronic complete occlusion of the carotid artery without obvious symptoms of cerebral ischemia;

3. Severe dementia;

4. The causes of cardiogenic embolism, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombosis or valve tumor, congestive heart failure, bacterial endocarditis, etc;

5. Uncontrolled hypertension (defined as systolic blood pressure = 180 mmHg or diastolic blood pressure = 110 mmHg, despite medication taken at enrollment);

6. Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl));

7. The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;

8. Pregnant or lactating women;

9. He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;

10. Other conditions that the researchers think are not suitable for the group.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.
• Sham remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who got =1 new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.	Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.	6 days
Secondary	The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.	Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.	6 days
Secondary	The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.	Patients underwent magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.	6 days
Secondary	Number of patients with cerebrovascular events, cardiovascular events or death.	Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.	90±7 days
Secondary	Proportion of patients with any side effects of Remote ischemic conditioning (RIC) treatment.	The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications and Carotid Endarterectomy (CEA).	6 days